About Krystal Bio:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal’s headquarters are two state-of-the-art GMP facilities.
Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland.
Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patents!
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated Maintenance Manager to provide technical and administrative leadership at our new greenfield GMP facility in Moon Township, PA. This is a hands-on role that involves direct contributions with troubleshooting as well as oversight of maintenance programs, facility optimization and consistent reliability.
- Leverage knowledge of GMP facilities and engineering processes, mechanical and utility systems and instrumentation to develop capabilities in diagnosis and troubleshooting of issues
- Triage and resolve issues related to maintenance process non-conformances
- Lead lifecycle assessments and provide recommendations for replacements and/or upgrades as needed to ensure consistent reliability
- Maintain awareness of industry and regulatory trends for calibration, instrumentation and maintenance
- Provide input for responses to regulatory inspections or internal audits relating to instrument calibrations or maintenance programs
- Perform daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a cGMP environment with minimal supervision
- Ensure safe and efficient hands-on maintenance of all manufacturing equipment and related support equipment with strict adherence to SOP's, cGMP's, and quality standards
- Identify any off-nominal conditions with mechanical equipment and mechanical troubleshooting of manufacturing/utility equipment in a clean room environment
- Execute daily Work Orders (WOs) and Preventative Maintenance (PM) items, and coordinate associated documentation and workflow
- Act as a subject matter expert for the Facilities and Maintenance group in relevant equipment and system root cause investigations and fill the role of lead investigator where required
- Ensure a safe work environment is maintained through adherence to safety guidelines and policies
- Provide on-call support during operation, project and shutdown activities, as required
Experience and Skills Desired:
- 6+ years of meaningful work experience in operations/manufacturing environment
- 3+ years of experience within highly regulated environments (i.e. cGMP, OSHA, EPA)
- Experience working with GMP systems, and in-depth technical knowledge of GMP instrumentation, highly preferred
- Demonstrated leadership attributes as an individual contributor (e.g., leadership of initiatives or participation on network level or continuous improvement teams)
- Strong background in process improvement methodologies
- Demonstrate a strong background in GMP Maintenance combined with excellent leadership and communication skills (written and verbal)
- Good interpersonal, communication and problem-solving skills
- Must be knowledgeable of the regulatory and GMP requirements for process equipment, instrumentation and calibration
- Knowledge of Six Sigma and lean systems is a plus
- Ability to make informed and timely decisions that consider the facts, goals, constraints, and associated risks
- A team player with a can-do, proactive attitude with a passion for continuous improvement
Krystal Biotech, Inc. is an Krystal Biotech, Inc.